Myhep-Mydekla

A Myhep-Mydekla tablet consist of two most conspicuous active substances which will exhibits anti-viral activity against hepatitis C viral infection.
Two components like;
Sofosbuvir; Daclatasvir
Myhep-Mydekla tablet which is approved by FDA and it is first established product comes under the combination of sofosbuvir and Daclatasvir.
Usually Daclatasvir is not used as monotherapy; it must be concomitant with sofosbuvir for potent anti-viral activity.
Myhep-Mydekla is a single dose therapy, with minimal adverse effects.
Myhep-Mydekla has better effectiveness in chronic hepatitis condition.

Sofosbuvir-Daclatasvir

Myhep-Mydekla

400mg & 60mg

Mylan

Myhep-Mydekla indicated for

The primary indications of Myhep-Mydekla tablets are;
Involved in advance or long-lasting hepatitis C viral infection mainly associated to genotype I or III.

The only drawback occurred in Myhep-Mydekla tablet taking patients;

There is a chance of reduction in virologic response rate in patients who are all receiving Myhep-Mydekla for 12 weeks in HCV genotype III conditions.
The usage of Myhep-Mydekla is only occurred in adolescents; not in pediatric patients.
The potency of Myhep-Mydekla tablet has not been evaluated in pediatric patients.

Myhep-Mydekla exhibits anti-viral activity by (mechanism)

Myhep-Mydekla in addition to tablet has two segments Sofosbuvir and Daclatasvir

Sofosbuvir is metabolized by liver, using carboxyl esterase 1 or cathepsin A as a catalyst
During metabolism sofosbuvir is converted into active uridine triphosphate
Daclatasvir is a substrate of CYP3A.

Before starting the therapy with Myhep-Mydekla tablets, patient undergone hepatic function test and examine the lab measurements.
If patient suspected with HBV infection, must be investigate by counting the hepatitis B surface antigen & hepatitis B core antibody.
Myhep-Mydekla tablet is containing 60mg of Daclatasvir & 400mg of sofosbuvir.
The usual dosage of Myhep-Mydekla is one tablet to be given orally as once a day.
Myhep-Mydekla tablet should be administered with or without food.

Patients with HCV genotype I infection:

Without cirrhosis or child Pugh A or B (compensated cirrhosis):
The usual dose of Myhep-Mydekla is one tablet should be given orally as once a day.
Decompensated cirrhosis (child Pugh C):
The usual recommended dosage is one tablet of Myhep-Mydekla should be administered orally as once daily by combining with ribavirin.

Patients with HCV genotype III infection:

Without cirrhosis or child Pugh A or B (compensated cirrhosis):
The recommended dose of Myhep-Mydekla is one tablet should be given orally as once a day.
In compensated, decompensated cirrhosis or post liver transplantation:
The recommended dosage of Myhep-Mydekla tablet is one tablet to be administered orally as a single dose.

Dosage recommendation of Ribavirin:

Patient with HCV related genotype I or III: The recommended dose of ribavirin is 600mg should be taken as an initial dose, followed by increasing up to 1000mg.
Patient with compensated cirrhosis: The dosage of ribavirin should be based on the body weight of the patients.
Based on the weight of the HCV suspected patients;
At least 75kg: 1200mg of ribavirin should be taken
Below 75kg: 1000mg should be taken
Ribavirin should be administered with or without food.

Over dosage

There are no known antitoxins forMyhep-Mydekla overdose. Therapy of overdose with Myhep-Mydekla should consist of general supportive measures, containchecking of vital signs and observation of the patient’s clinical status.

Myhep-Mydekla safety precautions

Use cautiously in the patients who are suspected with HBV infection, there is a chance of elevating the exposure of HBV reoccurrence in the patient co infected with HCV & HBV
Serious bradycardia occurs while concurrent use of Myhep-Mydekla tablet with amiodarone.

Increasing risk of loss of therapeutic effect occurs while concurrently use Myhep-Mydekla tablet with P-gp inducers or inhibitors
Severe adverse may occur due to drug interaction, to prevent this problem avoid this type of combinational therapy.

Myhep-Mydekla warning signs

Hepatitis B viral infection reactivation occurs in patient co infected with HCV & HBV; to avoid this problem patients must be undergone liver function test.
This may occur due to fail to take HBV anti-viral agents.

The major demerit of Myhep-Mydekla tablet is loss of virological response rate in patients with HCV infection related to genotype I or III with the duration of therapy for 12 weeks.
Serious life-threatening condition like bradycardia occurs while using Myhep-Mydekla with amiodarone.

Myhep-Mydekla tablets are concomitantly used with lipid lowering drugs causes increasing concentration of these drugs.

Myhep-Mydekla tablet combined with anti-convulsants, anti-mycobacterials or herbal products like st. Johns wort causes decreasing the effect of concentration of sofosbuvir.

Sofosbuvir is a P-gp or BCRP drug transporter substrate, while combining Myhep-Mydekla tablet with P-gp inducers causes decreasing the plasma concentration of sofosbuvir. This may results as loss of therapeutic effect.

Daclatasvir is a CYP3A substrate, while taking Myhep-Mydekla tablet with CYP3A strong inducers may causes loss of therapeutic effect of Daclatasvir.

Myhep-Mydekla combined with drugs inhibits the CYP3A may elevates the plasma level of Daclatasvir

Alteration in INR or prothrombin time may occur in patient receiving warfarin with Myhep-Mydekla tablets.

Myhep-Mydekla tablet combine with P-gp or BCRP inhibitors, may leads to cause prolonging the adverse effects of these substrates.

Contraindications

No contraindication occurs, while concurrently used with ribavirin are contraindicated to pregnancy.
Some anaphylactic reactions may occur due to the patients are contraindicated to the components present in the Myhep-Mydekla tablet.

If dose is missed, then have the dose immediately before the time of next dose or skip the missed dose and continue the normal schedule. Avoid having two doses at one time. Please consult to doctor for further information.

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